NEW DELHI :
US-based biopharmaceutical major Gilead Sciences said on Wednesday it is negotiating long-term voluntary licences with several generic drugmakers in India to produce remdesivir for developing countries.
Remdesivir is an investigational antiviral drug that is being studied in multiple ongoing international clinical trials but its safety and efficacy for the treatment of COVID-19 are not yet established.
"Gilead will provide appropriate technology transfers to facilitate this production," the company said in a statement.
"Gilead is in discussions with some of the world's leading chemical and pharmaceutical manufacturing companies about their ability, under voluntary licenses, to produce remdesivir for Europe, Asia and the developing world through at least 2022," it said.
The company is in active discussions with the Medicines Patent Pool, which Gilead has partnered with for many years, to licence remdesivir for developing countries.
"To further facilitate access in developing countries during this acute health crisis, Gilead is in advanced discussions with UNICEF to utilise their extensive experience providing medicines to low- and middle-income countries during an emergency and humanitarian crises to deliver remdesivir using its well-established distribution networks."
Close coordination of remdesivir manufacturing will be critical. "This is why Gilead is working to build a consortium of manufacturing partners -- to bring efforts together to help maximise global supply," said the company.
Producing the drug requires scarce raw materials, with their own lengthy production time, and specialised manufacturing capabilities with limited global capacity. Any disruption to the supply chain impacting these scarce raw materials and other manufacturing inputs could reduce the amount of remdesivir produced and increase the time it takes to do so.
Since January, said Gilead, it has worked with speed, care and diligence to prepare for the possibility that the company's investigational antiviral remdesivir may be found effective against the virus that causes COVID-19.
Recent clinical trial results and the decision by the US Food and Drug Administration to issue an emergency use authorisation for remdesivir have highlighted the urgency of this work and the importance of planning for access to remdesivir globally.
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